|Trade Name||SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM|
|Generic Name||intravascular stent with delivery system|
|Applicant||SCIMED LIFE SYSTEMS, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification ot the indications statement to include the treatment of saphenous vein graft lesions. The scimed radius(tm) coronary stent (14 mm and 20 mm lengths) with delivery system is indicated for use in patients with symptomaitc ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diamter ranging from 2. 75 to 4. 25 mm and is intended to improve coronary luminial diameter.